OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE), a global multi-modality specialty pharmaceutical contract development and manufacturing organization (CDMO), and Formycon AG (FSE: FYB, Prime Standard), an independent leader in biosimilar development headquartered in Munich, have announced a strategic manufacturing partnership to support the global supply of biosimilar medicines. Under the agreement, OneSource will serve as a strategic manufacturing partner for Formycon, providing integrated Drug Substance (DS) and Drug Product (DP) manufacturing capabilities from its advanced biologics manufacturing facility in Bengaluru.
The partnership brings together Formycon’s expertise in developing and commercializing high-quality biosimilars with OneSource’s end-to-end biologics manufacturing capabilities to support biosimilar programs targeting global markets. The collaboration reflects the shared commitment of both companies to expanding access to reliable, affordable and high-quality biologic therapies. By combining scientific innovation with scalable and cost-efficient manufacturing capabilities, OneSource and Formycon aim to strengthen the global biosimilar supply chain and enable broader patient access to critical medicines.
Formycon has established a strong reputation in biosimilar development, with a growing portfolio of approved products and a robust pipeline of future therapies. OneSource complements this expertise through a comprehensive biologics platform that spans cell line development, process development, clinical manufacturing and commercial-scale fill-finish operations. The company operates five manufacturing facilities approved by leading global regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with extensive experience across biologics, sterile injectables and drug-device combination products.
“This partnership brings together two organizations with a shared vision of making advanced biologic therapies more accessible worldwide,” said Neeraj Sharma, Managing Director and CEO of OneSource Specialty Pharma. “Formycon’s proven biosimilar development capabilities combined with OneSource’s integrated manufacturing platform create a strong foundation to support the next generation of global biosimilar products. This collaboration also highlights India’s growing role as a trusted hub for world-class pharmaceutical development and manufacturing.”
Dr Stefan Glombitza, Chief Executive Officer of Formycon AG, added, “Reliable, scalable and cost-efficient manufacturing is a critical component of our FYB4Growth strategy. By partnering with OneSource, we are strengthening our manufacturing network with an organization that shares our commitment to quality, operational excellence and supply reliability. Together, we will continue working to expand sustainable global access to life-changing biosimilar therapies.”
The partnership represents a significant step in advancing both companies’ capabilities in the global biosimilars market. Through their combined expertise, OneSource and Formycon will support the development, manufacturing and delivery of high-quality biologic medicines for patients worldwide.
OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE) is a global pure-play CDMO focused on complex pharmaceutical products, including biologics, drug-device combinations, sterile injectables and oral technologies such as soft gelatin capsules. With five state-of-the-art manufacturing facilities approved by global regulatory authorities and a team of more than 1,600 professionals, OneSource provides integrated development and manufacturing solutions for pharmaceutical companies worldwide.
Formycon AG (FSE: FYB) is a leading independent developer of high-quality biosimilars, covering the full value chain from candidate selection and development to regulatory approval, commercialization and global supply management. With marketed biosimilars including FYB201/ranibizumab, FYB202/ustekinumab and FYB203/aflibercept, along with a strong development pipeline, Formycon is committed to improving patient access to effective and affordable medicines.
